Company* | Product | Description | Indication | Status |
(Symbol) | (Date) | |||
CANCER | ||||
AVAX Technologies Inc. (AVXT) | M-Vax and O-Vax | Vaccines made from a patient's own cancer cells, modified with a hapten molecule that makes the tumor cells appear foreign to the patient's immune system to elicit a tumor-killing response | Melanoma and ovarian cancer | FDA commented in a letter the reasons the vaccines were put on clinical hold; the company expects to take three months to answer the FDA's questions (4/23) |
BioTransplant Inc. (BTRN) | BCell-HDM Cell Separation System | Designed to eliminate potentially malignant B cells from autologous stem cell transplants | Non-Hodgkin's lymphoma | Company, with merger partner Eligix Inc., received FDA clearance to initiate a pivotal Phase III trial (4/30) |
Ilex Oncology Inc. (ILXO) and Millennium Pharmaceuticals Inc. (MLNM) | Campath | Alemtuzumab; humanized monoclonal antibody | Chronic lymphocytic leukemia | FDA said it will take action on the BLA in May (4/6) |
Vysis Inc. (VYSI) and Genentech Inc. (NYSE:DNA) | Path Vysion HER-2 test | Determines which patients are candidates for Genentech's Herceptin (trastuzumab) therapy | Cancer | Companies filed a PMA for use of the test to determine which breast cancer patients are candidates for Genentech's Herceptin therapy (4/2) |
|
CARDIOVASCULAR | ||||
Scios Inc. (SCIO) | Natrecor | Nesitritide; recombinant form of B-type natriuretic peptide | Congestive heart failure | FDA's Cardiovascular and Renal Drugs Advisory Committee will review the NDA on May 25 (4/10) |
United Therapeutics Corp. (UTHR) | Remodulin (formerly UT-15) | Prostacyclin analogue | Pulmonary arterial hypertension | FDA extended for up to 90 days the priority review period for the NDA, allowing the FDA to review additional information submitted (4/15) |
|
CENTRAL NERVOUS SYSTEM | ||||
Amgen Inc. (AMGN) | Kineret | Interleukin-1 receptor antagonist; anakinra | Rheumatoid arthritis | Company submitted more information to the FDA to support its 1999 BLA filing (4/23) |
Celltech Pharmaceuticals Inc. (unit of the Celltech Group plc; UK; NYSE:CLL; LSE:CCH) | Metadate CD | Methylphenidate HCl extended-release 20 mg capsules | Attention deficit hyperactivity disorder | FDA granted marketing approval to treat patients 6 years or older (4/4) |
Orphan Medical Inc. (ORPH) | Xyrem | Sodium oxybate oral solution | Narcolepsy | FDA rescheduled an advisory committee review to June 6 (4/12) |
|
INFECTION | ||||
VaxGen Inc. (VXGN) | AIDSVAX | Made from a synthetic protein; AIDS vaccine | AIDS | A fifth review by the Data and Safety Monitoring Board found the AIDS vaccine still safe after 23,000 vaccine injections in Phase III trials (4/13) |
|
MISCELLANEOUS | ||||
Isotechnika Inc. (Canada; VSE:ISA) | ISAtx247 | Immunosuppressive agent based on cyclosporine | Kidney transplantation | Company filed applications with the FDA and Canadian authorities to begin Phase II trials (4/12) |
Genelabs Technologies Inc. (GNLB) | Aslera | Orally administered, highly purified prasterone, which is the synthetic equivalent of dehydroepiandrosterone | Lupus | FDA's Arthritis Advisory Committee met, but did not vote on whether to recommend approval of the NDA (4/19) |
Organogenesis Inc. (AMEX:ORG) | Fortaflex technology | Engineered collagen technology designed for internal repair applications | Soft tissue repair and wound dressing | Company submitted three marketing applications for Fortagen and Fortaperm to repair soft tissue, and Fortaderm for wound dressing (4/16) |
Ortec International Inc. (ORTC) | Composite cultured skin | Cryopreserved (frozen) version of CCS | Burns | FDA accepted the PMA (4/4) |
|
Notes: | ||||
* Privately held | ||||
Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market. | ||||
AMEX = American Stock Exchange; LSE = London Stock Exchange; NYSE = New York Stock Exchange; VSE = Vancouver Stock Exchange | ||||
BLA = Biologics License Application; NDA = New Drug Application; PMA = Premarket Approval Application | ||||
